Graft Vs Host DiseaseNCT03093805
Topical Vitamin D in Acute Graft Versus Host Disease of the Skin
A study testing Calcipotriene in people with Graft Vs Host Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients. Read more about this study
- Who is it for?
- Ages 3 months to 35 years
- Conditions the study is for
- Graft Vs Host Disease
- What is being tested?
- Calcipotriene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HSCT recipients with acute Grade I through III GVHD based on Glucksberg criteria. Recipients of multiple transplants are still eligible to participate in this research study.
- Each study subject is to have calcium and vitamin D level prior to starting study, if not obtained within 30 days of beginning treatment.
Who cannot join
- Patient with active cellulitis at the start of the treatment.
- Patients with hypercalcemia or vitamin D levels above 100 μg/L.
- Patients with known allergy to any of the topical therapy components.
- Patients who have received previous treatment with topical vitamin D cream.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Clinical Effectiveness of Calcipotriene in Acute Graft Versus Host Disease of the Skin: A Pilot Study
The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients. Calcipotriene will be used as the exclusive topical therapy in addition to standard of care GVHD treatment prescribed for the study subject by the primary physician.
Read the detailed description
Acute skin GVHD affects about one third of pediatric and adult transplant recipients. Chronic GVHD (cGVHD) affects 40-60% of adult patients who have undergone allogeneic HSCT. It is a major cause of non-relapse mortality and morbidity. Systemic prednisone is the first-line treatment for cGVHD; however, about one-half of all patients do not respond to this initial therapy, and there is no standard second-line therapy. Immunosuppressive therapy used for treatment of GVHD brings significant risk of infection, poorly affecting clinical outcomes.
Vitamin D affects immunoregulation, fibroblast proliferation, collagen synthesis and endothelial cell function, and the investigators hypothesize that topical vitamin D application will have a positive effect on acute and chronic skin GVHD. The investigators hypothesize that topical vitamin D cream may restore normal cell function and decrease the use of steroid creams in acute GVHD of the skin.
- Conditions
- Graft Vs Host Disease
- Being tested
- Calcipotriene
- Keywords
- Hematopoietic Stem Cell Transplant, Graft Versus Host Disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcipotrieneDietary supplement
Also called Dovonex
Topical vitamin D cream will be applied to affected areas of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriene | Experimental | Patients will apply Calcipotriene cream 2 times per day for 7 days. Receives: Dietary Supplement: Calcipotriene |
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD Grade
Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start15 Mar 2017
- Primary completion4 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Wallace, DO, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093805
- Sponsor's protocol ID
- 2016-6739
- Status last verified
- Jun 2019
- First submitted
- 23 Mar 2017
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Calcipotriene in Acute Graft Versus Host Disease of the Skin: A Pilot Study
- ClinicalTrials.gov ID
- NCT03093805
- Acronym / sponsor ID
- 2016-6739
- Conditions
- Graft Vs Host Disease
- Keywords
- Hematopoietic Stem Cell Transplant, Graft Versus Host Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients. Calcipotriene will be used as the exclusive topical therapy in addition to standard of care GVHD treatment prescribed for the study subject by the primary physician.
Detailed description
Acute skin GVHD affects about one third of pediatric and adult transplant recipients. Chronic GVHD (cGVHD) affects 40-60% of adult patients who have undergone allogeneic HSCT. It is a major cause of non-relapse mortality and morbidity. Systemic prednisone is the first-line treatment for cGVHD; however, about one-half of all patients do not respond to this initial therapy, and there is no standard second-line therapy. Immunosuppressive therapy used for treatment of GVHD brings significant risk of infection, poorly affecting clinical outcomes.
Vitamin D affects immunoregulation, fibroblast proliferation, collagen synthesis and endothelial cell function, and the investigators hypothesize that topical vitamin D application will have a positive effect on acute and chronic skin GVHD. The investigators hypothesize that topical vitamin D cream may restore normal cell function and decrease the use of steroid creams in acute GVHD of the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcipotriene | Experimental | Dietary Supplement: CalcipotrienePatients will apply Calcipotriene cream 2 times per day for 7 days. |
Who may qualify
- Ages
- 3 months to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- HSCT recipients with acute Grade I through III GVHD based on Glucksberg criteria. Recipients of multiple transplants are still eligible to participate in this research study.
- Each study subject is to have calcium and vitamin D level prior to starting study, if not obtained within 30 days of beginning treatment.
Key exclusion criteria (4 listed)
- Patient with active cellulitis at the start of the treatment.
- Patients with hypercalcemia or vitamin D levels above 100 μg/L.
- Patients with known allergy to any of the topical therapy components.
- Patients who have received previous treatment with topical vitamin D cream.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcipotrieneAlso: DovonexTopical vitamin D cream will be applied to affected areas of the skin. | Dietary supplement | Calcipotriene |
Primary outcome
GVHD Grade
Time frame: 7 days
Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Wallace, DO principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcipotriene in people with Graft Vs Host Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD Grade (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.